Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to distal limb arterial occlusion as assessed by Doppler
研究概览
简要总结
The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:
- Are AUTs effective in occlusion of blood flow
- Are AUTs easy to use
Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).
Following each application, the following parameters will be assessed:
- Limb blood flow
- Ease of use
Researchers will compare the results of the AUT and CAT to see if AUT is as effective as CAT in blood occlusion, and if AUT is easy to use as the CAT.
详细描述
The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:
- Are AUTs effective in occlusion of blood flow
- Are AUTs easy to use
Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Soldier in active service or active reserve service.
排除标准
- •Muscle disorders
- •Peripheral nerve disorders
- •Skin diseases of the limbs
- •Limb surgery in the past
- •Hypertension
研究组 & 干预措施
Automatic Tourniquet
Automatic pneumatic tourniquet
干预措施: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) (Device)
Combat Application Tourniquet (CAT)
Combat Application Tourniquet Generation 7
干预措施: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) (Device)
结局指标
主要结局
Time to distal limb arterial occlusion as assessed by Doppler
时间窗: 60 seconds
Time to distal limb arterial occlusion as assessed by Doppler is recorded
次要结局
- Usability of using automatic tourniquets(Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.)
- Safety of using automatic tourniquets(Will be assessed via questionnaire up to 5 minutes following the intervention.)
研究者
TOMER ERLICH
Head of Innovation, R&D Directorate, IDF Medical Corps Head of Medical Research, Directorate of Defense R&D, Israeli Ministry of Defense (IMOD DDR&D)
Medical Corps, Israel Defense Force